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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Microbiologic
510(k) Number K883052
Device Name METHENO-STAIN KIT
Applicant
Scientific Device Laboratory, Inc.
508 Zenith Dr.
Glenview,  IL  60025
Applicant Contact LIPTON, PHD
Correspondent
Scientific Device Laboratory, Inc.
508 Zenith Dr.
Glenview,  IL  60025
Correspondent Contact LIPTON, PHD
Regulation Number864.1850
Classification Product Code
JTS  
Date Received07/19/1988
Decision Date 08/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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